Feature | April 17, 2012

Medtronic Initiates Landmark U.S. Drug-Eluting Balloon Study

April 17, 2012 –– Expanding its commitment to developing innovative treatments for cardiovascular disease and the evidence to support their adoption, Medtronic announced the start of the Medtronic IN.PACT SFA II study, the company’s first U.S. clinical trial for its line of IN.PACT drug-eluting balloons.

The first patients in this landmark study were treated this week by Dr. Ash Jain at Washington Hospital in Fremont, Calif., and Brian Bigelow, M.D., at St. Vincent Hospital in Indianapolis; Monica Hunter, M.D., at Christ Hospital in Cincinnati is planning to treat a patient in the study as early as next week. Jain, Bigelow and Hunter are the principal investigators at their respective trial site.

Peripheral artery disease is estimated to affect eight to 12 million people in the United States alone. A prevalent form of cardiovascular disease, lower-extremity peripheral artery disease is a prime cause of claudication (ischemic leg pain) and immobility, critical limb ischemia and amputations.

The Medtronic IN.PACT SFA II study will evaluate the safety and effectiveness of the company’s IN.PACT Admiral drug-eluting balloon in the treatment of peripheral artery disease in the superficial femoral artery and/or proximal popliteal artery. Specifically, the trial will examine the effect of this novel device for treating de novo and lesions in these vessel beds.

The Medtronic IN.PACT SFA II study is a prospective, multicenter randomized controlled trial that will involve several hundred patients at up to 55 U.S. sites. Patients will be randomized 2:1 to treatment with either Medtronic’s IN.PACT Admiral drug-eluting balloon (study arm) or a traditional non-coated angioplasty balloon (control arm).

The principal investigators of the Medtronic IN.PACT SFA II study are interventional cardiologist John Laird, M.D., professor of medicine at the University of California Davis and medical director of the UC Davis Vascular Center, and vascular surgeon Peter Schneider, M.D., chief of the vascular therapy division at Kaiser Foundation Hospital and Hawaii Permanente Medical Group in Honolulu.

“Drug-eluting balloons represent an exciting and innovative therapy in the advancement of peripheral artery disease treatment,” said Laird. “The concept of delivering an anti-restenotic agent to the vessel while leaving nothing behind is very attractive.”

“Medtronic is a leader in the development of this novel drug-delivery device, and I am excited to partner with the company on IN.PACT SFA II. Dr. Schneider and I would also like to congratulate our colleagues at Washington Hospital, St. Vincent Hospital and Christ Hospital for being the first activated sites in this landmark study.”

Once complete, data from the Medtronic IN.PACT SFA II study will be combined with those from the Medtronic IN.PACT SFA I study –– currently underway in Europe and led by principal investigator Dr. Gunnar Tepe, chief of radiology at Klinikum Rosenheim in Germany –– and is intended to support a premarket approval (PMA) application to the U.S. Food and Drug Administration (FDA). The combined enrollment in the two Medtronic studies –– IN.PACT SFA I and II –– is expected to total approximately 450 patients.

Ultimately, Medtronic’s global IN.PACT clinical program will include 24 studies involving approximately 4,000 patients and 200 sites across more than 80 countries worldwide. Through these company-sponsored and physician-initiated studies, Medtronic IN.PACT drug-eluting balloons will be investigated thoroughly for the treatment of arterial disease in coronary and peripheral vessel beds. To date, seven of these studies have completed enrollment and 10 others have begun enrollment.

“As treatment of peripheral artery disease has moved to endovascular as a primary option, we are constantly seeking out more effective technologies for our patients,” said Schneider. “As data accumulates around the world, drug-eluting balloons may someday play a major role in treating narrowed arteries in the lower extremities. Dr. Laird and I are privileged to help assess this exciting new option for U.S. patients.”

Medtronic’s IN.PACT drug-eluting balloons feature a proprietary coating called FreePac that is a formulation of paclitaxel and urea, an excipient that facilitates absorption of the drug into the vessel wall. They received the CE (Conformité Européenne) mark in 2008 and 2009 and are available in many countries around the world. They are not commercially available in the United States; the Medtronic IN.PACT Admiral drug-eluting balloon is limited to investigational use under an investigational device exemption (IDE) granted by the FDA.

For more information www.inpactsfa2.com

Related Content

Edwards, Sapien 3, SOURCE 3 Registry, EuroPCR 2016
News | Heart Valve Technology| May 24, 2016
Thirty-day data from the European post-approval study of the Edwards Sapien 3 transcatheter aortic heart valve...
News | Cath Lab| May 24, 2016
The Society for Cardiovascular Angiography and Interventions (SCAI) 2016 Scientific Sessions took place May 4-7, 2016
HeartFlow, FFR-CT, ruptured coronary plaques, EMERALD study, EuroPCR 2016
News | CT Angiography (CTA)| May 23, 2016
First-in-human data presented at EuroPCR 2016 demonstrate that hemodynamic data from HeartFlow Inc. may help predict...
TAVR outcomes, aortic valve gradient, JACC study
News | Heart Valve Technology| May 23, 2016
Patients with a combination of left ventricular dysfunction and low aortic valve gradient have higher mortality rates...
Direct Flow Medical, TAVR device, DISCOVER trial, three-year results, EuroPCR 2016
News | Heart Valve Technology| May 20, 2016
Direct Flow Medical Inc. presented three-year results from its prospective, multicenter DISCOVER Trial at the EuroPCR...
PCI, OFDI, OCT, optical coherence tomography, optimal frequency domain imaging, EuroPCR 2016 study
News | Intravascular Imaging| May 20, 2016
Using optimal frequency domain imaging (OFDI) to guide percutaneous coronary intervention (PCI) with second-generation...
Watchman, left atrial appendage closure, LAA occluder, LAA. LAAO, laa occluder, left atrial appendage, Watchman

The Boston Scientific Watchman device is currently the only transcatheter LAA occluder cleared for use in the United States.

Feature | Left Atrial Appendage (LAA) Occluders| May 20, 2016 | Dave Fornell
Atrial fibrillation (AF) affects nearly 6 million Americans and the condition puts them at significantly greater risk
Bioventrix, Revivent-TC System, heart failure, first-in-man procedure
News | Heart Failure| May 19, 2016
BioVentrix announced the first-in-man use of its next-generation Revivent-TC System with an endovascular catheter-based...
St. Jude Medical, EuroPCR 2016 studies, FFR, LAAO, left atrial appendage occlusion, fractional flow reserve, Amplatzer
News | Cath Lab| May 19, 2016
St. Jude Medical Inc. announced results from two cardiovascular clinical trials presented at EuroPCR 2016.
clot, coronary thrombus, antiplatelet therapt, DAPT

An intravascular ultrasound (IVUS) image of a thrombus formed in a coronary artery.  While there are guidelines for antiplatelet therapy, there are still questions over the duration of such therapy. 

Feature | Antiplatelet and Anticoagulation Therapies| May 19, 2016 | Marianne Pop, Pharm.D., BCPS
There are many opinions on the duration of dual antiplatelet therapy (DAPT), highlighted at the 2016 American College
Overlay Init